The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps

NCT ID: NCT03238573

Last Updated: 2017-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-19

Study Completion Date

2019-12-01

Brief Summary

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When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp will be resected for the biopsy.

Detailed Description

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When discovering a polyp, the endoscopist uses water to wash it.Then, the endoscopist starts with i-scan 1 (OE mode 1) to observe the polyp closely .Nextly, the endoscopist give a real-time optical diagnosis with the blind of the history of patient. Considering the other polyps, the endoscopist gives a surveillance interval predictions according to the guide made by USMSTF.The confidence of the real-time optical diagnosis is divided into high confidence and low confidence.After the observation, the small and diminutive polyp will be resected and have the blinded pathology.

Conditions

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Colorectal Sessile Serrated Adenomas/Polyps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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optical enhancment endoscopy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. The high risk for colorectal cancer screening score
2. Patients with colorectal polyps reviewing

Exclusion Criteria

* 1.Inflammatory bowel disease 2. Polyposis syndrome 3. A history of colorectal cancer or surgical resection 4. Poor bowel preparation5.Not signing the informed consent 6.Severe cardiopulmonary function failure lesions, severe hypertension, cerebrovascular disease, mental disorder and coma, pregnancy, lactation can't taking the colonoscopy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li, MD,PhD

Role: STUDY_DIRECTOR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology,Qilu Hospital,Shandong University

Jin'an, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, MD,PhD

Role: CONTACT

86-531-82169236

Facility Contacts

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Yanqing Li, MD,PhD

Role: primary

86-531-82169236

References

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Erichsen R, Baron JA, Hamilton-Dutoit SJ, Snover DC, Torlakovic EE, Pedersen L, Froslev T, Vyberg M, Hamilton SR, Sorensen HT. Increased Risk of Colorectal Cancer Development Among Patients With Serrated Polyps. Gastroenterology. 2016 Apr;150(4):895-902.e5. doi: 10.1053/j.gastro.2015.11.046. Epub 2015 Dec 8.

Reference Type RESULT
PMID: 26677986 (View on PubMed)

IJspeert JE, Bastiaansen BA, van Leerdam ME, Meijer GA, van Eeden S, Sanduleanu S, Schoon EJ, Bisseling TM, Spaander MC, van Lelyveld N, Bargeman M, Wang J, Dekker E; Dutch Workgroup serrAted polypS & Polyposis (WASP). Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps. Gut. 2016 Jun;65(6):963-70. doi: 10.1136/gutjnl-2014-308411. Epub 2015 Mar 9.

Reference Type RESULT
PMID: 25753029 (View on PubMed)

Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857. doi: 10.1053/j.gastro.2012.06.001. Epub 2012 Jul 3. No abstract available.

Reference Type RESULT
PMID: 22763141 (View on PubMed)

Other Identifiers

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2017SDU-QILU-03

Identifier Type: -

Identifier Source: org_study_id

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